BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOKNEE TOTAL KNEE SYSTEM

    MDR report key: 21424051 · Received February 20, 2025

    Report

    Report Number
    3014273644-2025-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 21, 2025
    Report Date
    February 17, 2025
    Manufacturer
    NOVOSOURCE, LLC
    Product Code
    JWH
    UDI-DI
    00811382036538
    PMA / PMN Number
    K131398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY A UC TIBIAL INSERT TRIAL SIZE 2 (3311-4012) WAS INSERTED, THE SURGEON PUT THE PATIENT KNEE THROUGH A RANGE OF MOTION, AND UPON REMOVAL THE UC TIBIAL INSERT TRIAL SIZE 2 (3311-4012) FRACTURED. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY OR DEATH, THAT THE SURGERY WAS NOT PROLONGED AND FINALLY THAT THE DEVICE WAS USED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464652 NOVOKNEE TOTAL KNEE SYSTEM KNEE PROSTHESIS JWH NOVOSOURCE, LLC 3311-4012 PSV016876 00811382036538

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female